Aquestive Therapeutics, Inc. — Form 8-K
Filed November 3, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 68/100
What the filing says
Aquestive resubmitted its New Drug Application for Anaphylm (dibutepinephrine sublingual film) on September 16, 2026, with FDA acceptance on a Class 2 basis and PDUFA goal date of March 16, 2027. If approved, Anaphylm would be the first and only oral epinephrine rescue medication for severe allergic reactions. The company also out-licensed Libervant to Eton Pharmaceuticals in October 2026 for $10M upfront plus up to $47.5M in contingent payments and mid-teens royalties; Q3 2026 revenues fell 41% YoY to $7.6M; cash declined to $90.3M from $121.2M year-start.
Why this rating
NDA resubmission with 16-month PDUFA goal is pivotal for Aquestive's lead asset—approval would create first-to-market oral epinephrine product. Libervant $10M upfront + royalties meaningfully strengthen $291.6M-cap company balance sheet. Revenue decline and $90.3M cash (vs. ~$291.6M market cap; 31% burn rate) show execution risk but commercial preparation underway.
See more from November 3, 2026.
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